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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, surgical, ceiling mounted
510(k) Number K142984
Device Name Leo Minor
Applicant
SUNNEX, INC.
9319 FORSYTH PARK DRIVE
CHARLOTTE,  NC  28273
Applicant Contact TISH MENDICK
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number878.4580
Classification Product Code
FSY  
Date Received10/16/2014
Decision Date 10/29/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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